MAUDE Adverse Event Report: OXYHEALTH CORPSOLACE PERSONAL HEALTH SYSTEMHYPERBARIC CHAMBER

Event Date 10/04/2002

Event Type  Malfunction  

Event Description

The international congress on hyperbaric medicine (ichm) is holding their tri-annual scientific meeting. The oxyhealth corp has two portable, fabric mild hyperbaric chambers on display: the vitaeris 320 and the solace personal health system. Their exhibit is physically located immediately across the room from the rptr's display. At approx 1030 hrs, one of the oxyhealth corp sales rep was preparing the solace personal health system for a demonstration dive for one of the delegates. When the sales rep was attempting to connect the air compressor to the chamber there was a loud pop. Rptr was at their display immediately across the room from the oxyhealth exhibit talking with two other meeting delegates. After hearing the pop they looked up to see the sales rep looking around the floor for something. Rptr looked down to discover a plastic quick disconnect valve on the floor approx two feet from where they were standing. Rptr presumes that the valve was not connected properly and the popping sound heard was the valve as it disconnected after initial pressurization. Further, rptr assumes that it was propelled across the room and bounced to the floor after hitting the back drape of the display booth. Rptr does not know the amount of pressure at the time of failure. Rptr picked up the valve and gave it back to the sales rep. The sales rep simply thanked rptr for giving it back.

• Brand Name: SOLACE PERSONAL HEALTH SYSTEM
• Type of Device: HYPERBARIC CHAMBER
• Manufacturer (Section F): OXYHEALTH CORP; *
• Manufacturer (Section D): OXYHEALTH CORP; *
• Device Event Key: 410005
• MDR Report Key: 420970
• Event Key: 398134
• Report Number: MW1026371
• Device Sequence Number: 1
• Product Code: CBF
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/04/2002
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Invalid Data
• OTHER Device ID Number: NI
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: Yes
• Event Location: PUBLIC VENUE
• Was The Report Sent To Manufacturer?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

Patient TREATMENT DATA

Date Received: 10/04/2002 Patient Sequence Number: 1

#	Treatment	Treatment Date
NA